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As nine of the first 30 patients (30%) met this criterion, the study was opened to the second stage and an additional 25 patients were enrolled.
Concerning the primary composite criterion, the study did not find any significant difference between the two groups, although the p-value was at the limit of significance (6 %).
However, as two of the patients had met their individual FEV1 discontinuation criterion, the study discontinuation criterion "Two or more subjects, who receive AZD9164, have other clinically significant changes in laboratory values or other safety parameters" was also met.
However, in the SMART-AV trial the primary endpoint was not based on a clinical composite criterion, the study lasted only 6 months and no VVD optimization was performed.
A potential limitation of our study might be that we chose to use the BPI average pain intensity item as the pain intensity criterion, the study was performed with moderate sample, and patients' recruitment was from one center.
One point was accredited for each positive criterion: the study participants were randomized; the study groups had similar characteristics at baseline; the groups were treated equally except for the test intervention; all patients were accounted for; outcome assessors were blinded to the intervention or used well-defined outcome criteria; and outcomes were compared on an intention-to-treat basis.
Similar(54)
The contrast between numbers receiving disability benefits and those getting social care funding is likely to reflect different eligibility criteria, the study suggests.
With respect to ecologic criteria, the study considers resources and energy consumption as also the resulting CO2 equivalent emissions.
Third, as to other selection criteria, the study results show some interesting differences between consideration and choice.
After selection for study criteria, the study cohort consisted of 70 patients who agreed to participate.
Using these criteria, the study was based on 6218 examinations in 547 children.
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